Documented information
Documented information is the ISO term for information you have to control, together with whatever it sits on: a policy, a procedure, a register, a record, a wiki page. Newer ISO management system standards use it in place of “documents” and “records”, and signal the difference with two verbs: you maintain a document and retain a record.
- Clauses
- ISO 27001:2022 7.5 · ISO 9001:2015 7.5 · ISO 13485:2016 4.2.4 · ISO 13485:2016 4.2.5 · ISO 42001:2023 7.5
Where the term appears
ISO 27001:2022 7.5, ISO 9001:2015 7.5 and ISO 42001:2023 7.5 cover the information the standard requires plus whatever else you decide you need. Each item is identified, reviewed and approved when created or changed, and controlled so the right version is available, protected, distributed, retained and disposed of, including documents from outside that you rely on. ISO 13485 kept the older words: ISO 13485:2016 4.2.4 controls documents and ISO 13485:2016 4.2.5 controls records, each through a documented procedure, with records kept at least for the device’s lifetime and never less than two years from release.
Maintain or retain
“Maintain” means keep current: the scope, a policy, a procedure. “Retain” means keep as evidence of what happened: an audit report, a training record, review minutes. An auditor checks that the version in use is the approved one and that records were not edited after the event.
How Sted uses it
- An administrator, or a Policy and Process Owner who owns the document, approves a Draft or starts a new version of an Approved one, and only an administrator assigns a document’s owner; a document still awaiting review cannot be approved.
- Administrators and a document’s owner can open superseded versions from History.
- A record is opened, completed, submitted for closure and closed (or withdrawn); closure is reviewed by the document owner.
Related terms
- Evidence: what retained records become at audit.
- ISMS: the management system whose information this is.
- QMS: where ISO 13485 still says documents and records.
- Approved document: the version people should be working from.
- Document control: versioning, approval and review dates, step by step.